FDA Inspection
Sage Pharmaceuticals, Inc.Sage Pharmaceuticals, Inc. – FDA Inspection, Feb 17, 2012
Record Details
This FDA Inspection record concerns Sage Pharmaceuticals, Inc., with an inspection on February 17, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sage Pharmaceuticals, Inc.
- Inspection Date
- February 17, 2012
- Product Type
- Drugs
View Company Profile
ID · a0124234-9419-4962-8c08-f1ce6aa2ed97
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 768299
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
7- 21 CFR 211.110(a)Control procedures fail to include the following
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Sage Pharmaceuticals, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 6, 2011 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| April 22, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sage Pharmaceuticals, Inc.
- FDA Inspection 724336 - 2011-05-06
- FDA Inspection 577809 - 2009-04-22
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